← Back to Search

BRAF Inhibitor

Immunotherapy + Targeted Therapy for Melanoma

Phase 3
Waitlist Available
Led By Michael B Atkins
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >= 18 years. Because no dosing or adverse event data are currently available on the use of dabrafenib or dabrafenib + trametinib or nivolumab or nivolumab + ipilimumab therapy in patients < 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
Age >= 18 years
Must not have
History of lymphoproliferative disorder
Other current malignancies, except specified exceptions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is testing two different treatments for melanoma that cannot be removed by surgery. The first treatment is immunotherapy with monoclonal antibodies, followed by targeted therapy with dabrafenib and trametinib. The second treatment is targeted therapy with dabrafenib and trametinib, followed by immunotherapy with monoclonal antibodies. It is not yet known which treatment is more effective.

Who is the study for?
Adults with stage III-IV melanoma that can't be surgically removed and have the BRAFV600 mutation. They should not have HIV, other cancers within the last 5 years (except certain skin cancers), serious medical conditions, or be pregnant/breastfeeding. Participants must agree to use effective contraception.Check my eligibility
What is being tested?
The trial is testing two treatment sequences for advanced melanoma: starting with ipilimumab and nivolumab (immunotherapies) followed by dabrafenib and trametinib (targeting BRAFV600 gene), versus starting with dabrafenib and trametinib followed by immunotherapies, to see which is more effective.See study design
What are the potential side effects?
Possible side effects include immune system reactions affecting organs, infusion-related reactions from antibodies, heart issues due to targeted therapies, liver problems, skin rash, fever, fatigue, eye problems like blurred vision or dry eyes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I am 18 years old or older.
Select...
My cancer is at an advanced stage and cannot be removed with surgery.
Select...
My cancer has a BRAF V600 mutation confirmed by an approved test.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My melanoma cannot be removed by surgery and has been confirmed by tests.
Select...
My melanoma has the BRAF V600 mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of disorders related to lymphocyte proliferation.
Select...
I do not have any other cancers, except for allowed exceptions.
Select...
I have a history of heart problems or risks.
Select...
I am HIV positive.
Select...
I am not using any medications or therapies that are not allowed in the study.
Select...
I don't have issues swallowing or absorbing medications.
Select...
I have had a blockage in the veins of my retina.
Select...
I have an active cancer other than basal or squamous cell skin cancer.
Select...
I have brain metastases that are currently treated and stable.
Select...
I have lung scarring or inflammation.
Select...
I have an autoimmune disease that could come back and affect my organs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival (OS) rate
Secondary outcome measures
Progression-free survival (PFS)
Response rate
Toxicity rate for categorized AEs
+2 more
Other outcome measures
Change in patient-reported symptoms
Genetic characteristics
Immune-related adverse events (irAE) status
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Arm D (immunotherapy)Experimental Treatment7 Interventions
IMMUNOTHERAPY INDUCTION (CYCLES 1-2): Patients receive nivolumab IV over 30-60 minutes and ipilimumab IV over 30-90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. IMMUNOTHERAPY MAINTENANCE (CYCLES 3-14): Patients receive nivolumab IV over 30-60 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial.
Group II: Arm C (BRAF inhibitor therapy)Experimental Treatment7 Interventions
Patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO daily on days 1-42. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial.
Group III: Arm B (BRAF inhibitor therapy)Experimental Treatment7 Interventions
Patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO daily on days 1-42. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm D. Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial.
Group IV: Arm A (immunotherapy)Experimental Treatment7 Interventions
IMMUNOTHERAPY INDUCTION (CYCLES 1-2): Patients receive nivolumab IV over 30-60 minutes and ipilimumab IV over 30-90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. IMMUNOTHERAPY MAINTENANCE (CYCLES 3-14): Patients receive nivolumab IV over 30-60 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm C. Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Multigated Acquisition Scan
2015
Completed Phase 2
~50
Biospecimen Collection
2004
Completed Phase 2
~1720
Computed Tomography
2017
Completed Phase 2
~2720
Dabrafenib Mesylate
2014
Completed Phase 2
~10
Echocardiography
2013
Completed Phase 4
~11670
Ipilimumab
2014
Completed Phase 3
~2610
Trametinib Dimethyl Sulfoxide
2014
Completed Phase 2
~10
Nivolumab
2014
Completed Phase 3
~4740

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,959,101 Total Patients Enrolled
4 Trials studying Cutaneous Melanoma
198 Patients Enrolled for Cutaneous Melanoma
Michael B AtkinsPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Dabrafenib Mesylate (BRAF Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02224781 — Phase 3
~14 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top